Identification of Biomarkers for Early Detection of Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00897494
First received: May 9, 2009
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is examining blood samples from patients with cancer to identify biomarkers that may help in the early detection of pancreatic cancer.


Condition Intervention
Pancreatic Cancer
Genetic: protein expression analysis
Other: laboratory biomarker analysis
Other: mass spectrometry
Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Michigan Center for Pancreatic Cancer Molecular Diagnosis: The Serum Protein Microarray Project

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Identification of specific proteins of interest to evaluate for their potential role as markers for pancreatic cancer [ Time Frame: Upon collection when patient agrees to provide a one time venous blood collection ] [ Designated as safety issue: No ]
  • Analysis of serum proteins directly by mass spectrometry to identify new biomarkers of pancreatic cancer that can be used for early diagnosis [ Time Frame: After separation from the plasma ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Venous blood


Enrollment: 75
Study Start Date: February 2005
Study Completion Date: April 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Genetic: protein expression analysis
    Venous blood collection
    Other: laboratory biomarker analysis
    Venous blood collection
    Other: mass spectrometry
    Venous blood collection
    Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry
    Venous blood collection
Detailed Description:

OBJECTIVES:

  • Identify specific proteins of interest to evaluate for their potential role as markers for pancreatic cancer.
  • Analyze serum proteins directly by mass spectrometry to identify new biomarkers of pancreatic cancer that can be used for early diagnosis.

OUTLINE: Blood from patients is collected prior to treatment. Plasma proteins are analyzed by matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF/MS) and/or electrospray mass spectrometry (ESI/MS).

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Venous blood collection samples from newly dianosed

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of pancreatic cancer

    • Newly diagnosed disease
  • Planning to undergo surgery or other treatment for pancreatic cancer at Karmanos Cancer Institute or its affiliates

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897494

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Fazlul Sarkar, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00897494     History of Changes
Other Study ID Numbers: CDR0000479140, P30CA022453, WSU-C-2737, WSU-013105MP2E
Study First Received: May 9, 2009
Last Updated: March 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014